Operation Manual
40 Pages
Preview
Page 1
INSTRUCTIONS
OES BRONCHOFIBERSCOPE
OLYMPUS BF TYPE N20
Refer to the endoscope’s companion manual, the “OLYMPUS BF/ENF/LF ENDOSCOPE REPROCESSING MANUAL” for reprocessing information. USA: CAUTION: Federal law restricts this device to sale by or on the order of a physician.
Contents
Contents Symbols...
1
Important Information - Please Read Before Use...
2
Intended Use ...
2
Instruction Manual ...
2
User Qualifications ...
2
Instrument Compatibility...
3
Reprocessing and Storage ...
3
Repair and Modification ...
3
Signal Words...
4
Warnings and Cautions ...
4
Chapter 1
Checking the Package Contents...
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Checking the Package Contents...
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Instrument Nomenclature and Specifications ...
8
2.1
Nomenclature...
8
2.2
Endoscope Functions ...
10
2.3
Specifications...
11
Preparation and Inspection ...
13
3.1
Preparation of the Equipment ...
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3.2
Preparation and Inspection of the Endoscope ...
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3.3
Preparation, Inspection and Connection of the Ancillary Equipment
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3.4
Inspection of the Endoscopic System ...
16
Operation ...
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4.1
Insertion ...
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4.2
Withdrawal of the Endoscope ...
20
4.3
Transportation of the Endoscope...
21
Troubleshooting ...
22
5.1
Troubleshooting Guide...
22
5.2
Returning the Endoscope for Repair...
23
Appendix ...
24
System Chart ...
24
EMC information ...
27
1.1
Chapter 2
Chapter 3
Chapter 4
Chapter 5
BF-N20 OPERATION MANUAL
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Contents
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BF-N20 OPERATION MANUAL
Symbols
Symbols The meaning(s) of the symbol(s) shown on the package with the components, the back cover of this instruction manual and/or this instrument are as follows:
Refer to instructions.
Caution
Type BF applied part
Endoscope
Manufacturer
Authorized representative in the European Community
Lot number
Serial number
BF-N20 OPERATION MANUAL
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Important Information - Please Read Before Use
Important Information - Please Read Before Use Intended Use This instrument has been designed to be used with an Olympus Light Source, documentation equipment, display monitor and other ancillary equipment for endoscopic diagnosis within the airways and tracheobronchial tree. Do not use this instrument for any purpose other than its intended use.
Instruction Manual This instruction manual contains essential information on using this instrument safely and effectively. Before use, thoroughly review this manual and the manuals of all equipment which will be used during the procedure and use the instruments as instructed. Note that the complete instruction manual set for this endoscope consists of this manual and the “OLYMPUS BF/ENF/LF ENDOSCOPE REPROCESSING MANUAL” which also accompanied the endoscope at shipment. Keep this and all related instruction manuals in a safe, accessible location. If you have any questions or comments about any information in this manual, please contact Olympus.
User Qualifications The operator of this instrument must be a physician or medical personnel under the supervision of a physician and must have received sufficient training in clinical endoscopic technique. This manual, therefore, does not explain or discuss clinical endoscopic procedures.
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BF-N20 OPERATION MANUAL
Important Information - Please Read Before Use
Instrument Compatibility Refer to the “System Chart” in Appendix to confirm that this instrument is compatible with the ancillary equipment being used. Using incompatible equipment can result in patient injury or equipment damage. This instrument complies with EMC standard for medical electrical equipment; edition 2 (IEC 60601-1-2: 2001). However, when connected with an instrument that complies with EMC standard for medical electrical equipment; edition 1 (IEC 60601-1-2: 1993), the whole system complies with edition 1.
Reprocessing and Storage This instrument was not disinfected or sterilized before shipment. Before using this instrument for the first time, reprocess it according to the instructions in the endoscope’s companion manual, the “OLYMPUS BF/ENF/LF ENDOSCOPE REPROCESSING MANUAL”. After using this instrument, reprocess and store it according to the instructions in the “OLYMPUS BF/ENF/LF ENDOSCOPE REPROCESSING MANUAL”. Improper and/or incomplete reprocessing or storage can present an infection control risk, cause equipment damage or reduce performance.
Repair and Modification This instrument does not contain any user-serviceable parts. Do not disassemble, modify or attempt to repair it; patient or user injury and/or equipment damage can result. Problems that appear not to be malfunctions may be correctable by referring to Chapter 5, “Troubleshooting”. If the problem cannot be resolved using the information in Chapter 5, contact Olympus.
BF-N20 OPERATION MANUAL
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Important Information - Please Read Before Use
Signal Words The following signal words are used throughout this manual:
Indicates a potentially hazardous situation which, if not avoided, could result in death or serious injury.
Indicates a potentially hazardous situation which, if not avoided, may result in minor or moderate injury. It may also be used to alert against unsafe practices or potential equipment damage.
Indicates additional helpful information.
Warnings and Cautions Follow the warnings and cautions described below when handling this instrument. This information is supplemented by the warnings and cautions described in each chapter.
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•
Never perform angulation forcibly or suddenly. Never forcefully pull or twist the angulated bending section. Patient injury, bleeding and/or perforation can result. It may also become impossible to straighten the bending section during use and/or to withdraw this instrument from the patient. Particular caution is required in the tracheal bifurcation region.
•
Never insert or withdraw the endoscope while the endoscope’s bending section is locked in position. When withdrawing the endoscope, the bending section should follow the form of the body cavity as much as possible. Otherwise, patient injury, bleeding and/or perforation can result. It may also become impossible to straighten the bending section during use and/or to withdraw this instrument from the patient.
•
Never perform angulation control or insertion/withdrawal of the endoscope’s Insertion Tube without viewing the endoscopic image. Patient injury can result.
BF-N20 OPERATION MANUAL
Important Information - Please Read Before Use
•
Do not touch the Light Guide immediately after removing it from the Light Source because it is extremely hot.
•
Do not pull the Universal Cord. The Endoscope Connector will be pulled out from the output socket of the Light Source and the endoscopic image will not be visible.
•
Do not coil the Insertion Tube and Universal Cord with a diameter of less than 10 cm. Equipment damage can result.
•
Do not hit the Distal End of the Insertion Tube or allow it to strike other objects. The objective lens surface of the Distal End is particularly fragile, and vision abnormalities may result.
•
Do not twist or bend the Bending Section by hands. Equipment damage may result.
•
Do not squeeze the Bending Section forcefully. The covering of the Bending Section may stretch or break and cause water leaks.
•
Do not hit or bend the Electrical Contacts on the Endoscope Connector. The connection to the Light Source may be impaired and faulty contact can result.
•
Electromagnetic interference may occur on this instrument near equipment marked with the following symbol or other portable and mobile RF (Radio Frequency) communications equipment such as cellular phones. If electromagnetic interference occurs, mitigation measures may be necessary, such as reorienting or relocating this instrument, or shielding the location.
Details on clinical endoscopic technique are the responsibility of trained specialists. Patient safety in endoscopic examinations and endoscopic treatment can be ensured through appropriate handling by the physician and the medical facility. Examples of inappropriate handling are given below. •
Using improperly reprocessed or stored instruments may cause patient cross-contamination and infection.
•
Patient injury may be caused by: Inserting or withdrawing the endoscope without a clear endoscopic view; forcefully pulling, twisting or rotating the angulated Bending Section.
BF-N20 OPERATION MANUAL
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Important Information - Please Read Before Use
•
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The endoscope has not been designed for use in retroflexed observation. Performing retroflexed observation in a narrow lumen may make it impossible to straighten the bending section and/or withdraw the endoscope from the patient. In case the patient moves due to coughing and other reasons while the endoscope is angulated in the narrow lumen, the bending section of the endoscope may be pushed into the lumen and be retroflexed. Pretreatment to control patient’s coughing reflex and other possible unexpected moves is the responsibility of trained specialists.
BF-N20 OPERATION MANUAL
Chapter 1 Checking the Package Contents
Chapter 1 Checking the Package Contents 1.1
Checking the Package Contents Match all items in the package with the components shown below. Inspect each item for damage. If the instrument is damaged, a component is missing or you have any questions, do not use the instrument; immediately contact Olympus. This instrument was not disinfected or sterilized before shipment. Before using this instrument for the first time, reprocess it according to the instructions in the endoscope’s companion manual, the “OLYMPUS BF/ENF/LF ENDOSCOPE REPROCESSING MANUAL”.
Endoscope
Protection Tube (MD-515) ETO Cap (MB-156)
Mouthpiece (MA-651, 2 pieces)
BF-N20 OPERATION MANUAL
Instruction Manual (Operation)
Instruction Manual (Reprocessing)
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Chapter 2 Instrument Nomenclature and Specifications
Chapter 2 Instrument Nomenclature and Specifications 2.1
Nomenclature
Universal Cord
5. Eyepiece Frame (Viewfinder) 6. Diopter Adjustment Ring
3. UP/DOWN Angulation Lock Eyepiece Section
2. UP/DOWN Angulation Control Lever
Electrical Contacts Control Section
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BF-N20 OPERATION MANUAL
Boot
Chapter 2 Instrument Nomenclature and Specifications
Venting Connector Light Guide
Serial Number Electrical Contacts
4. Endoscope Connector
1. Bending Section Distal End
Insertion Tube/Working Length
BF-N20 OPERATION MANUAL
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Chapter 2 Instrument Nomenclature and Specifications
2.2
Endoscope Functions 1. Bending Section Moves the Distal End of the endoscope by operating the UP/DOWN Angulation Control Lever. 2. UP/DOWN Angulation Control Lever When turned in the “U” direction, the Bending Section moves UP; when turned in the “D” direction, the Bending Section moves DOWN. 3. UP/DOWN Angulation Lock Turning this lever in the “F ” direction frees angulation. Turning the lever in the opposite direction locks the Bending Section at any desired position. 4. Endoscope Connector Connects to the Light Source. Transmits light from the Light Source to the endoscope. 5. Eyepiece Frame (Viewfinder) The Viewfinder contains an index mark indicating the UP direction of the Bending Section. 6. Diopter Adjustment Ring Adjusts the operator’s focus. This does not affect focusing for photography.
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BF-N20 OPERATION MANUAL
Chapter 2 Instrument Nomenclature and Specifications
2.3
Specifications Environment Operating environment
Ambient temperature
10 – 40°C (50 – 104°F)
Relative humidity
30 – 85%
Atmospheric pressure
700 – 1060 hPa (0.7 – 1.1 kgf/cm2) (10.2 – 15.4 psia)
Standard storage Ambient temperature environment (e.g. Relative humidity within the hospital) Atmospheric pressure
5 – 40°C (41 – 104°F) 10 – 95% 700 – 1060 hPa (0.7 – 1.1 kgf/cm2) (10.2 – 15.4 psia)
Transportation Ambient temperature environment Relative humidity (conditions during Atmospheric pressure transportation and short-term storage)
–47 to 70°C (–52.6 to 158°F) 10 – 95% 700 – 1060 hPa (0.7 – 1.1 kgf/cm2) (10.2 – 15.4 psia)
Specifications Optical System
Insertion Tube
Bending Section
Field of View
75°
Depth of Field
2 – 50 mm
Distal End Outer Diameter
ø 1.8 mm
Flexible Tube Outer Diameter
ø 2.2 mm
Working Length
550 mm
Angulation Range
UP 160°, DOWN 90°
Total Length
BF-N20 OPERATION MANUAL
770 mm
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Chapter 2 Instrument Nomenclature and Specifications
Medical Devices Directive
EMC
This device complies with the requirements of Directive 93/42/EEC concerning medical devices. Classification: Class II a Applied standard; IEC 60601-1-2: 2001
This instrument complies with the standards listed in the left column. CISPR 11 of emission: Group 1, Class B This instrument complies with the EMC standard for medical electrical equipment; edition 2 (IEC 60601-1-2: 2001). However, when connecting to an instrument that complies with the EMC standard for medical electrical equipment; edition 1 (IEC 60601-1-2: 1993), the whole system complies with edition 1.
Year of manufacture
2712345 The last digit of the year of manufacture is given in the second digit of the serial number.
Degree of protection against electric shock
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BF-N20 OPERATION MANUAL
TYPE BF applied part
Chapter 3 Preparation and Inspection
Chapter 3 Preparation and Inspection
3.1
•
Before each case, prepare and inspect this instrument as instructed below. Inspect other equipment that are used with this instrument as instructed in their respective instruction manuals. Should the slightest irregularity be suspected, do not use this instrument and see Chapter 5, “Troubleshooting”. If the irregularity is still suspected after consulting Chapter 5, contact Olympus. Damage or irregularity may compromise patient or user safety and may result in more-severe equipment damage.
•
This instrument was not disinfected or sterilized before shipment. Before using this instrument for the first time, reprocess it according to the instructions in the endoscope’s companion manual, the “OLYMPUS BF/ENF/LF ENDOSCOPE REPROCESSING MANUAL”.
Preparation of the Equipment According to the “System Chart” in Appendix, prepare this instrument, ancillary equipment, paper towels, basin, lint-free cloth and personal protective equipment, such as eye wear, a face mask, moisture-resistant clothing and chemical-resistant gloves, for the particular case. Refer to the respective instruction manual for each piece of equipment.
Endoscope
Mouthpiece
Light Source
Figure 3.1 BF-N20 OPERATION MANUAL
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Chapter 3 Preparation and Inspection
3.2
Preparation and Inspection of the Endoscope Clean and disinfect (or sterilize) the endoscope as described in the “OLYMPUS BF/ENF/LF ENDOSCOPE REPROCESSING MANUAL”.
Inspection of the Endoscope 1. Visually inspect the Control Section and the Endoscope Connector for excessive scratching.
2. Visually inspect the Boot and the Insertion Tube near the Boot for bends, twists or other irregularities.
3. Visually inspect the surface of the Insertion Tube for dents, bulges, swelling or other irregularities.
4. Carefully run your fingertips over the entire length of the Insertion Tube. Inspect for any protruding objects or other irregularities (see Figure 3.2).
Figure 3.2
5. Visually inspect the covering of the Bending Section for sagging, swelling, cuts, holes or other irregularities.
6. Loosely hold the midpoint of the Bending Section and a point 10 cm from the Distal End. Push and pull gently to confirm that there is no play.
7. Visually inspect the Objective Lens at the Distal End of the endoscope’s Insertion Tube for dents, bulges, swelling or other irregularities.
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BF-N20 OPERATION MANUAL
Chapter 3 Preparation and Inspection
8. Confirm that the Diopter Adjustment Ring turns smoothly and that the Eyepiece Section is attached securely to the Control Section. Confirm that the eyepiece is free of defects, such as scratches or deformations.
When cleaning or wiping the eyepiece lens surface, do not use abrasive cleansers because they may scratch the lens surface.
9. Wipe the Eyepiece Section and Light Guide edges of the Endoscope Connector using a clean, lint-free cloth moistened with 70% ethyl or isopropyl alcohol.
Inspection of the Bending Mechanisms Perform the following inspections while the Bending Section is straight.
Inspection for Smooth Operation
1. Confirm that the UP/DOWN Angulation Lock is placed in the “F
” position.
2. Turn the UP/DOWN Angulation Control Lever slowly in each direction until it stops. Confirm that the Bending Section angulates smoothly and correctly and that maximum deflection can be achieved.
3. Turn the UP/DOWN Angulation Control Lever slowly to its neutral position. Confirm that the Bending Section returns smoothly to an approximately straight condition.
Inspection of the Angulation Mechanism
1. Turn the UP/DOWN Angulation Lock in the opposite direction of the “F
” mark. Then turn the UP/DOWN Angulation Control Lever in the “U” direction until it stops.
2. Confirm that the angle of the Bending Section is roughly stabilized when you remove your thumb from the UP/DOWN Angulation Control Lever.
3. Confirm that the Bending Section returns to its straight position when the UP/DOWN Angulation Lock is turned in the “F ” direction and you remove your thumb from the UP/DOWN Angulation Control Lever.
BF-N20 OPERATION MANUAL
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Chapter 3 Preparation and Inspection
3.3
Preparation, Inspection and Connection of the Ancillary Equipment Preparation and Inspection of Ancillary Equipment Prepare and inspect the Light Source according to the instruction manual for the Light Source.
Connection of the Endoscope and Ancillary Equipment Insert the Endoscope Connector completely into the output socket of the Light Source. If required, prepare and inspect the camera, display monitor and video system according to their instruction manuals.
3.4
Inspection of the Endoscopic System Inspection of the Endoscopic Image 1. Turn the Light Source ON according to the instruction manual for the Light Source. When using the EVIS Universal Light Source, set the mode switch to “OES”.
2. Adjust the brightness level as appropriate. 3. Turn the Diopter Adjustment Ring until the fiber pattern is clear. Confirm that an object approximately 8 mm from the Objective Lens can be seen clearly.
If the object cannot be seen clearly, wipe the Objective Lens using a clean, lint-free cloth moistened with 70% ethyl or isopropyl alcohol.
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BF-N20 OPERATION MANUAL
Chapter 4 Operation
Chapter 4 Operation The operator of this instrument must be a physician or medical personnel under the supervision of a physician and must have received sufficient training in clinical endoscopic technique. This manual, therefore, does not explain or discuss clinical endoscopic procedures. It only describes basic operation and precautions related to the operation of this instrument.
•
Anytime you suspect an abnormality in an endoscope function, stop the examination immediately and slowly remove it while viewing the endoscopic image. Using a defective endoscope may cause patient injury.
•
If the endoscopic image should unexpectedly disappear, stop the examination immediately, turn the UP/DOWN Angulation Lock in the “F ” direction, then, without touching the Angulation Control Lever slowly withdraw the endoscope from the patient.
•
If the angulation control mechanism or any other part of the system is not functioning properly, stop the procedure immediately; free the Angulation Lock and do not operate the Angulation Control Lever unless absolutely necessary. Then carefully withdraw the endoscope while observing the endoscopic image. If the endoscope cannot be withdrawn from the patient smoothly, do not attempt to forcibly withdraw it; leave it inside the patient and immediately contact Olympus. Forcibly withdrawing the endoscope may cause patient injury.
•
Use personal protective equipment to guard against dangerous chemicals and potentially infectious material. During operation, wear appropriate protective equipment, such as eye wear, a face mask, moisture-resistant clothing and chemical-resistant gloves that fit properly and are long enough so that your skin is not exposed.
BF-N20 OPERATION MANUAL
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